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510(k) K970686

ACCUTEMP-PROBE by Kentec Medical, Inc. — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1997
Date Received
February 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Infant Radiant
Device Class
Class II
Regulation Number
880.5130
Review Panel
HO
Submission Type

Other clearances by Kentec Medical, Inc.

  • K120272 — AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET (February 17, 2012)
  • K100526 — AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (April 22, 2010)
  • K050443 — ACCU-LEAD (September 2, 2005)
  • K960080 — ACCUTEMP PROBE (May 1, 1996)
  • K853475 — GRAM-MA NEONATAL SC (September 5, 1985)

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